BACKGROUND: Social prescribing link workers are non-health or social care professionals who connect people with psychosocial needs to non-clinical community supports. They are being implemented widely, but there is limited evidence for appropriate target populations or cost effectiveness. This study aimed to explore the feasibility, potential impact on health outcomes and cost effectiveness of practice-based link workers for people with multimorbidity living in deprived urban communities.
METHODS: A pragmatic exploratory randomised trial with wait-list usual care control and blinding at analysis was conducted during the COVID 19 pandemic (July 2020 to January 2021). Participants had two or more ongoing health conditions, attended a general practitioner (GP) serving a deprived urban community who felt they may benefit from a one-month practice-based social prescribing link worker intervention.. Feasibility measures were recruitment and retention of participants, practices and link workers, and completion of outcome data. Primary outcomes at one month were health-related quality of life (EQ-5D-5L) and mental health (HADS). Potential cost effectiveness from the health service perspective was evaluated using quality adjusted life years (QALYs), based on conversion of the EQ-5D-5L and ICECAP-A capability index to utility scoring.
RESULTS: From a target of 600, 251 patients were recruited across 13 general practices. Randomisation to intervention (n = 123) and control (n = 117) was after baseline data collection. Participant retention at one month was 80%. All practices and link workers (n = 10) were retained for the trial period. Data completion for primary outcomes was 75%. There were no significant differences identified using mixed effects regression analysis in EQ-5D-5L (MD 0.01, 95% CI -0.07 to 0.09) or HADS (MD 0.05, 95% CI -0.63 to 0.73), and no cost effectiveness advantages. A sensitivity analysis that considered link workers operating at full capacity in a non-pandemic setting, indicated the probability of effectiveness at the €45,000 ICER threshold value for Ireland was 0.787 using the ICECAP-A capability index.
CONCLUSIONS: While the trial under-recruited participants mainly due to COVID-19 restrictions, it demonstrates that robust evaluations and cost utility analyses are possible. Further evaluations are required to establish cost effectiveness and should consider using the ICE-CAP-A wellbeing measure for cost utility analysis.
BACKGROUND: This trial is registered on ISRCTN.
BACKGROUND: Use of link workers to provide social prescribing and health and social care coordination for people with complex multimorbidity in socially deprived areas.
BACKGROUND: ISRCTN10287737. Date registered 10/12/2019. Link: https://www.isrctn.com/ISRCTN10287737.

BACKGROUND: The promise of artificial intelligence (AI) to transform health care is threatened by a tangle of challenges that emerge as new AI tools are introduced into clinical practice. AI tools with high accuracy, especially those that detect asymptomatic cases, may be hindered by barriers to adoption. Understanding provider needs and concerns is critical to inform implementation strategies that improve provider buy-in and adoption of AI tools in medicine.
OBJECTIVE: This study aimed to describe provider perspectives on the adoption of an AI-enabled screening tool in primary care to inform effective integration and sustained use.
METHODS: A qualitative study was conducted between December 2019 and February 2020 as part of a pragmatic randomized controlled trial at a large academic medical center in the United States. In all, 29 primary care providers were purposively sampled using a positive deviance approach for participation in semistructured focus groups after their use of the AI tool in the randomized controlled trial was complete. Focus group data were analyzed using a grounded theory approach; iterative analysis was conducted to identify codes and themes, which were synthesized into findings.
RESULTS: Our findings revealed that providers understood the purpose and functionality of the AI tool and saw potential value for more accurate and faster diagnoses. However, successful adoption into routine patient care requires the smooth integration of the tool with clinical decision-making and existing workflow to address provider needs and preferences during implementation. To fulfill the AI tool\'s promise of clinical value, providers identified areas for improvement including integration with clinical decision-making, cost-effectiveness and resource allocation, provider training, workflow integration, care pathway coordination, and provider-patient communication.
CONCLUSIONS: The implementation of AI-enabled tools in medicine can benefit from sensitivity to the nuanced context of care and provider needs to enable the useful adoption of AI tools at the point of care.
BACKGROUND: ClinicalTrials.gov NCT04000087; https://clinicaltrials.gov/ct2/show/NCT04000087.

UNASSIGNED: Pragmatic trials often implement an intervention across a population of patients but require information unavailable at the population level that must be reported by a subset of patients. In this pragmatic clinical trial, we compared characteristics of seriously ill patients with those who completed a survey evaluating advance care planning across 3 academic health systems.
UNASSIGNED: A deliberate process including health system and external stakeholders and patients was used to design materials for and the approach to seriously ill patients. We developed a survey and conducted a multistep process to identify seriously ill primary care patients. We evaluated the relationships of age, gender, race and ethnicity, and vulnerability using the social vulnerability index in this population, and explored the representativeness of survey respondents compared with the underlying seriously ill population in terms of age, race and ethnicity, and vulnerability measured.
UNASSIGNED: About 5% (8707 patients) of the primary care population was classified as seriously ill, 5351 were mailed a survey and 1100 provided survey responses. Hispanic and Black patients were younger than White patients, and Black and Hispanic patients were more vulnerable than White and Asian patients and patients of other races. Representativeness was high across age and race and ethnicity, although White and Hispanic patients were more likely to respond than Black and Asian patients and patients of other races. Vulnerability in the surveyed sample was nearly identical to the population.
UNASSIGNED: A tailored survey and recruitment strategy yielded a representative sample of seriously ill, largely older, primary care respondents in the context of a pragmatic clinical trial.

BACKGROUND: Improving perinatal mental health and care experiences and preventing adverse maternal and infant outcomes are essential prenatal care components, yet existing services often miss the mark, particularly for low-income populations. An enhanced group prenatal care program, \"Glow! Group Prenatal Care and Support,\" was developed in California\'s Central Valley in response to poor perinatal mental health, disrespectful care experiences, and high rates of adverse birth outcomes among families with low incomes.
METHODS: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) is a pragmatic, two-arm, randomized, comparative-effectiveness study designed to assess depression (primary outcome), the experience of care (secondary outcome), and preterm birth (exploratory outcome) among Medi-Cal (California\'s Medicaid program)-eligible pregnant and birthing people, comparing those assigned to Glow! Group Prenatal Care and Support (Glow/GC) with those assigned to enhanced, individual prenatal care through the California Department of Public Health\'s Comprehensive Perinatal Services Program (CPSP/IC). Participating clinical practices offer the two comparators, alternating between comparators every 6 weeks, with the starting comparator randomized at the practice level. Participant-reported outcomes are assessed through interviewer-administered surveys at study entry, during the participant\'s third trimester, and at 3 months postpartum; preterm birth and other clinical outcomes are abstracted from labor and delivery records. Patient care experiences are further assessed in qualitative interviews. The protocol complies with the Standard Protocol Items for Randomized Trials.
CONCLUSIONS: This comparative-effectiveness study will be used to determine which of two forms of enhanced prenatal care is more effective, informing future decisions regarding their use.
BACKGROUND: ClinicalTrials.gov: NCT04154423.

BACKGROUND: Cirrhosis treatment implies prevention and alleviation of serious disease events. Healthcare providers may, however, fail to meet patients\' expectations of collaboration and specific needs of information and support. Individualised nursing care could meet patients\' needs. The aim was thus to measure patient-perceived quality of care after adjunctive registered nurse-based intervention Quality Liver Nursing Care Model (QLiNCaM) compared with standard medical care.
METHODS: This pragmatic multicentre study consecutively randomised patients to either adjunctive registered nurse-based care, or standard medical care for 24 months (ClinicalTrials.gov NCT02957253). Patients were allocated to either group at an equal ratio, at six Swedish outpatient clinics during 2016-2022. Using the questionnaire \'Quality of care from the patient\'s perspective\', patients rated their perceived lack of quality for the adjunctive registered nurse-based intervention compared with the control group at 12 and 24 months, respectively.
RESULTS: In total, 167 patients were recruited. Seven out of 22 items in the questionnaire supported the finding that \'lacking quality\' decreased with adjunctive registered nurse-based care (p < 0.05) at 12 months follow-up; however, these differences could not be established at 24 months.
CONCLUSIONS: Additional structured registered nurse-based visits in the cirrhosis outpatient team provided support for improved patient-perceived quality of care during the first 12 months. Registered nurses increase patient involvement and present easy access to cirrhosis outpatient care. Patients express appreciation for personalised information. This study reinforces registered nurses\' role in the outpatient cirrhosis team, optimising patient care in compensated and decompensated cirrhosis.
BACKGROUND: Registered at Clinical Trials 18th of October 2016, [ https://www.
RESULTS: gov ], registration number: NCT02957253.

UNASSIGNED: To describe the recruitment, retention of family caregivers, and adherence to a telephone based intervention evaluated in a multi-site trial and provide recommendations for the design of future studies.
UNASSIGNED: A descriptive study based on a secondary analysis of a multi-site clinical development in Colombia and Brazil. Recruitment was measured by the number of participants eligible and consented. Retention was assessed by the percentage of participants with outcomes data at two follow-ups. The intervention adherence was measured by the percentage of the caregiver who received the intervention.
UNASSIGNED: Of the family caregivers assessed, 63% were eligible, and 32.9% declined to be in the study for time restriction or no interest. In Colombia, the total retention rate of caregivers was 63.4% at the first follow-up and 48% at the second follow-up, while in Brazil was de 52.8% and 46.2%, respectively. At the end of the study, the sample comprised 28 and 70 caregivers in the intervention and control groups, respectively, for a retention rate of 47%. Of 104 family caregivers allocated to the intervention group, 42 (40.3%) received five sessions. Most reported not completing the Caregiver\'s Activity Diary.
UNASSIGNED: The recruitment of family caregivers, participant retention, and adherence to the telephone intervention was unsuccessful. Future studies should apply an assessment tool during the recruitment of family caregivers and replace the term \"caregiver\" with \"care provider\" in the material involved in the research; define a retention protocol before starting the study and involve family caregivers in the design of the interventions.

BACKGROUND: The prevalence of obesity and its associated comorbidities continue to rise in the United States. Populations who are uninsured and from racial and ethnic minority groups continue to be disproportionately affected. These populations also experience fewer clinically meaningful outcomes in most weight loss trials. Weight gain prevention presents a useful strategy for individuals who experience barriers to weight loss. Given the often-limited weight management resources available to patients in primary care settings serving vulnerable patients, evaluating interventions with pragmatic designs may help inform the design of comprehensive obesity care delivered in primary care.
OBJECTIVE: This study aims to evaluate the effectiveness of Balance, a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention, delivered to patients receiving primary care within federally qualified community health centers.
METHODS: Balance was a 2-arm, 12-month pragmatic randomized controlled trial of a digital weight gain prevention intervention delivered to individuals who had a BMI of 25-40 kg/m2, spoke English or Spanish, and were receiving primary care within a network of federally qualified community health centers in North Carolina. The Balance intervention was designed to encourage behavioral changes that result in a slight energy deficit. Intervention participants received tailored goal setting and tracking, skills training, self-monitoring, and responsive health coaching from registered dietitians. Weight was measured at regular primary care visits and documented in the electronic health record. We compared the percentage of ≤3% weight gain in each arm at 24 months after randomization-our primary outcome-using individual empirical best linear unbiased predictors from the linear mixed-effects model. We used individual empirical best linear unbiased predictors from participants with at least 1 electronic health record weight documented within a 6-month window centered on the 24-month time point.
RESULTS: We randomized 443 participants, of which 223 (50.3%) participants were allocated to the intervention arm. At baseline, participants had a mean BMI of 32.6 kg/m2. Most participants were Latino or Hispanic (n=200, 45.1%) or non-Latino or Hispanic White (n=115, 26%). In total, 53% (n=235) of participants had at least 1 visit with weight measured in the primary time window. The intervention group had a higher proportion with ≤3% weight gain at 6 months (risk ratio=1.12, 95% CI 0.94-1.28; risk difference=9.5, 95% CI -4.5 to 16.4 percentage points). This difference attenuated to the null by 24 months (risk ratio=1.00, 95% CI 0.82-1.20; risk difference=0.2, 95% CI -12.1 to 11.0 percentage points).
CONCLUSIONS: In adults with overweight or obesity receiving primary care at a community health center, we did not find long-term evidence to support the dissemination of a digital health intervention for weight gain prevention.
BACKGROUND: ClinicalTrials.gov NCT03003403; https://clinicaltrials.gov/study/NCT03003403.
UNASSIGNED: RR2-10.1186/s12889-019-6926-7.

BACKGROUND: Chronic low back pain (cLBP) is highly prevalent in the United States and globally, resulting in functional impairment and lowered quality of life. While many treatments are available for cLBP, clinicians have little information about which specific treatment(s) will work best for individual patients or subgroups of patients. The Back Pain Research Consortium, part of the National Institutes of Health Helping to End Addiction Long-termSM (HEAL) Initiative, will conduct a collaborative clinical trial, which seeks to develop a personalized medicine algorithm to optimize patient and provider treatment selection for patients with cLBP.
OBJECTIVE: The primary objective of this article is to provide an update on evidence-based cLBP interventions and describe the process of reviewing and selecting interventions for inclusion in the clinical trial.
METHODS: A working group of cLBP experts reviewed and selected interventions for inclusion in the clinical trial. The primary evaluation measures were strength of evidence and magnitude of treatment effect. When available in the literature, duration of effect, onset time, carryover effect, multimodal efficacy, responder subgroups, and evidence for the mechanism of treatment effect or biomarkers were considered.
CONCLUSIONS: The working group selected 4 leading, evidence-based treatments for cLBP to be tested in the clinical trial and for use in routine clinical treatment. These treatments include (1) duloxetine, (2) acceptance and commitment therapy, (3) a classification-based exercise and manual therapy intervention, and (4) a self-management approach. These interventions each had a moderate to high level of evidence to support a therapeutic effect and were from different therapeutic classes.
UNASSIGNED: HINTERGRUND: Chronischer Schmerz im unteren Rücken („chronic low back pain“ [cLBP]) hat in den Vereinigten Staaten und auch weltweit eine hohe Prävalenz. Er führt zu funktioneller Beeinträchtigung und verringert die Lebensqualität. Während für cLBP viele Therapien verfügbar sind, liegen wenige Informationen darüber vor, welche spezifische Therapie bzw. welche spezifischen Therapien beim individuellen Patienten oder in einer Subgruppe von Patienten am besten wirkt bzw. wirken. Das Back Pain Research Consortium, ein Teilbereich der National Institutes of Health Helping to End Addiction Long-termSM (HEAL) Initiative, wird eine kooperative klinische Studie durchführen, in der ein personalisierter medizinischer Algorithmus entwickelt werden soll, um die Wahl der Therapie durch Patienten und Behandler für Patienten mit cLBP zu optimieren. ZIEL: Hauptziele des vorliegenden Beitrags sind eine aktualisierte Übersicht zu evidenzbasierten cLBP-Interventionen und eine Beschreibung des Begutachtungs- und Auswahlprozesses für den Einschluss von Interventionen in die klinische Studie.
METHODS: Eine Arbeitsgruppe von cLBP-Experten prüfte und wählte Interventionen für den Einschluss in die klinische Studie aus. Primäre Beurteilungsmaße waren die Evidenzstärke und die Größe des Therapieeffekts. Soweit in der Literatur verfügbar wurden Wirkdauer, Anschlagzeit, Carry-over-Effekt, multimodale Wirksamkeit, Responder-Subgruppen und Evidenz für den Mechanismus des Therapieeffekts oder Biomarker berücksichtigt.
UNASSIGNED: Die Arbeitsgruppe wählte vier maßgebende evidenzbasierte Therapien bei cLBP für die Testung in der klinischen Studie und für die Anwendung in der routinemäßigen klinischen Behandlung aus. Diese Therapien umfassen (1) die Gabe von Duloxetin, (2) Akzeptanz- und Commitment-Therapie, (3) eine klassifikationsbasierte Übungs- und manuelle Therapieintervention und (4) einen Selbstmanagementansatz. Der Evidenzlevel für einen Therapieeffekt war bei jeder dieser Interventionen moderat bis hoch, zudem stammen sie aus verschiedenen therapeutischen Klassen.

BACKGROUND: Given significant risks associated with long-term prescription opioid use, there is a need for non-pharmacological interventions for treating chronic pain. Activating patients to manage chronic pain has the potential to improve health outcomes. The ACTIVATE study was designed to evaluate the effectiveness of a 4-session patient activation intervention in primary care for patients on long-term opioid therapy.
METHODS: The two-arm, pragmatic, randomized trial was conducted in two primary care clinics in an integrated health system from June 2015-August 2018. Consenting participants were randomized to the intervention (n = 189) or usual care (n = 187). Participants completed online and interviewer-administered surveys at baseline, 6- and 12- months follow-up. Prescription opioid use was extracted from the EHR. The primary outcome was patient activation assessed by the Patient Activation Measure (PAM). Secondary outcomes included mood, function, overall health, non-pharmacologic pain management strategies, and patient portal use. We conducted a repeated measure analysis and reported between-group differences at 12 months.
RESULTS: At 12 months, the intervention and usual care arms had similar PAM scores. However, compared to usual care at 12 months, the intervention arm demonstrated: less moderate/severe depression (odds ratio [OR] = 0.40, 95%CI 0.18-0.87); higher overall health (OR = 3.14, 95%CI 1.64-6.01); greater use of the patient portal\'s health/wellness resources (OR = 2.50, 95%CI 1.42-4.40) and lab/immunization history (OR = 2.70, 95%CI 1.29-5.65); and greater use of meditation (OR = 2.72; 95%CI 1.61-4.58) and exercise/physical therapy (OR = 2.24, 95%CI 1.29-3.88). At 12 months, the intervention arm had a higher physical health measure (mean difference 1.63; 95%CI: 0.27-2.98).
CONCLUSIONS: This trial evaluated the effectiveness of a primary care intervention in improving patient activation and patient-reported outcomes among adults with chronic pain on long-term opioid therapy. Despite a lack of improvement in patient activation, a brief intervention in primary care can improve outcomes such as depression, overall health, non-pharmacologic pain management, and engagement with the health system.
BACKGROUND: The study was registered on 10/27/14 on ClinicalTrials.gov (NCT02290223).

UNASSIGNED: Pragmatic trials are increasingly recognized for providing real-world evidence on treatment choices.
UNASSIGNED: The objective of this study is to investigate the use and characteristics of pragmatic trials in multiple sclerosis (MS).
UNASSIGNED: Systematic literature search and analysis of pragmatic trials on any intervention published up to 2022. The assessment of pragmatism with PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) is performed.
UNASSIGNED: We identified 48 pragmatic trials published 1967-2022 that included a median of 82 participants (interquartile range (IQR) = 42-160) to assess typically supportive care interventions (n = 41; 85%). Only seven trials assessed drugs (15%). Only three trials (6%) included >500 participants. Trials were mostly from the United Kingdom (n = 18; 38%), Italy (n = 6; 13%), the United States and Denmark (each n = 5; 10%). Primary outcomes were diverse, for example, quality-of-life, physical functioning, or disease activity. Only 1 trial (2%) used routinely collected data for outcome ascertainment. No trial was very pragmatic in all design aspects, but 14 trials (29%) were widely pragmatic (i.e. PRECIS-2 score ⩾ 4/5 in all domains).
UNASSIGNED: Only few and mostly small pragmatic trials exist in MS which rarely assess drugs. Despite the widely available routine data infrastructures, very few trials utilize them. There is an urgent need to leverage the potential of this pioneering study design to provide useful randomized real-world evidence.